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Bioequivalence Study of Two Formulations of Pregabalin CR(Controlled-release) Table 300 mg

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ClinicalTrials.gov Identifier: NCT02952937
Recruitment Status : Completed
First Posted : November 2, 2016
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
GL Pharm Tech Corporation

Brief Summary:
The purpose of this clinical trial is to (1) evaluate the bioequivalence(BE) of GLA5PR GLARS-NF3 tablet 300mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 300mg administered regular diet and (2) determine the safety and tolerability of a single dose of GLA5PR GLARS-NF3 tablet 300mg administered regular diet and GLA5PR GLARS-NF1 tablet 300mg administered regular diet.

Condition or disease Intervention/treatment Phase
Healthy Drug: GLA5PR GLARS-NF3 tablet 300mg Drug: GLA5PR GLARS-NF1 tablet 300mg Phase 1

Detailed Description:
To assess the single dose pharmacokinetics, safety, and tolerability of GLA5PR GLARS-NF3 tablet 300mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 300mg administered regular diet. IP will be administered 1 tablet(300mg) once a day(QD) after evening meal.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized, Open-label, Single Dose, Crossover Phase 1 Study to Compare the Pharmacokinetic Characteristics of GLA5PR GLARS-NF1 Tablet 300 mg and GLA5PR GLARS-NF3 Tablet 300 mg in Healthy Volunteers
Study Start Date : November 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : April 2017


Arm Intervention/treatment
Group 1
  1. Period 1: GLA5PR GLARS-NF1 tablet 300mg , 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO).
  2. wash-out period: over 7 days.
  3. Period 2: GLA5PR GLARS-NF3 tablet 300mg, 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO).
Drug: GLA5PR GLARS-NF3 tablet 300mg
A new formulation(3rd.) of Pregabalin CR tablet
Other Name: Test drug

Drug: GLA5PR GLARS-NF1 tablet 300mg
A new formulation(1st.) of Pregabalin CR tablet
Other Name: Comparator drug

Group 2
  1. Period 1: GLA5PR GLARS-NF3 tablet 300mg , 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO).
  2. wash-out period: over 7 days.
  3. Period 2: GLA5PR GLARS-NF1 tablet 300mg , 1 tab, once a day(QD), after evening meal(Regular Diet), oral administration(PO).
Drug: GLA5PR GLARS-NF3 tablet 300mg
A new formulation(3rd.) of Pregabalin CR tablet
Other Name: Test drug

Drug: GLA5PR GLARS-NF1 tablet 300mg
A new formulation(1st.) of Pregabalin CR tablet
Other Name: Comparator drug




Primary Outcome Measures :
  1. AUClast of Pregabalin [ Time Frame: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points) ]
  2. Cmax of Pregabalin [ Time Frame: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points) ]

Secondary Outcome Measures :
  1. AUCinf of Pregabalin [ Time Frame: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points) ]
  2. Tmax of Pregabalin [ Time Frame: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points) ]
  3. t1/2 of Pregabalin [ Time Frame: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points) ]
  4. CL/F of Pregabalin [ Time Frame: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points) ]
  5. Vd/F of Pregabalin [ Time Frame: Immediately pre-dose(0h), post-dose 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 hr(14 points) ]

Other Outcome Measures:
  1. Adverse events, Vital signs, Physical examinations, Clinical safety laboratories and 12-lead EKG. [ Time Frame: Through study completion(Post-study Visit), an average of 1 month ]
    Post-study Visit: upto 3 ~7 days after last PK sample collection



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects who, at the time of screening, are the age of older than 19 years.
  • Subjects who have BMI more than 17.5kg/m2 and less than 30.5kg/m2 and body weight more than 55kg.
  • There is no congenital disease or within 3 years of chronic diseases.
  • Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG) or clinical laboratory tests.
  • Subjects who signed and dated the informed consent form(approved by IRB) after understanding fully to hear a detailed explanation in the clinical trial
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • A subject with any history of gastrointestinal disease (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products.
  • A subject who has the following clinical laboratory test results

    ☞ Liver Function Test (AST, ALT) > three times the upper limit of the normal range

  • History of regular alcohol consumption exceeding 210g/week(12g = 125 mL of wine, 10g = 250 mL of beer, 10g = 50 mL of hard liquor) within 6 months of Screening.
  • A subject who has participated in any other clinical trials and had medication within 3 months prior to the first administration of investigational product. (The end date of another clinical trial is based on the last day of the administration)
  • A subject who has the following vital signs results in sitting position at the time of the screening :

SBP ≤ 90 mmHg or DBP ≤ 60 mmHg.

  • A subject with a history of drug abuse or a positive urine drug screening for drug abuse
  • A subject who has taken the drugs that induce and suppress drug-metabolizing enzymes within 30 days prior to investigational product administration.
  • A smoker who consumes more than 20 cigarettes/days
  • A subject who has taken any ethical-the-counter drug or has taken any over-the-counter drug within 10days before the investigational product administration
  • A subject who has donated whole blood within 2 months or blood components within 1 month prior to the investigational product administration
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
  • A subject who is unable to take regular diet during the study period.
  • Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs
  • History of sensitivity to pregabalin, gabapentin, or other alpha2 delta ligands.
  • Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
  • A subject who is not eligible for the study due to reasons on the investigators' judgment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952937


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju-si, Jeollabuk-do, Korea, Republic of, 54907
Sponsors and Collaborators
GL Pharm Tech Corporation
Investigators
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Principal Investigator: Min-Gul Kim, Ph.D. Chonbuk National University Hospital

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Responsible Party: GL Pharm Tech Corporation
ClinicalTrials.gov Identifier: NCT02952937     History of Changes
Other Study ID Numbers: GLAPR-106
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GL Pharm Tech Corporation:
Neuralgia, Postherpetic
Postherpetic Neuralgia
Diabetic Neuropathies
Diabetic Neuralgia
Diabetic Polyneuropathy
Diabetic Neuropathy, Painful
Neuralgia
Neuropathic Pain
Pregabalin
Pharmacokinetics
Bioequivalent
Additional relevant MeSH terms:
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Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs